orBec® - for the treatment of gastrointestinal symptoms associated with chronic Graft-versus-Host disease

orBec®; is specifically formulated for oral administration as a single product consisting of two tablets (each containing 1 mg of beclomethasone 17,21-dipropionate or BDP). One tablet releases BDP in the upper gastrointestinal (GI) tract and the other tablet releases BDP in the lower GI tract. BDP is a highly potent, topically active corticosteroid. The Office of Orphan Products Development of the United States Food and Drug Administration (FDA) has granted Orphan Drug Designation to BDP for the treatment of GI symptoms associated with chronic Graft-versus-Host disease (cGVHD) in patients who have undergone allogeneic hematopoietic cell transplantation.

About Chronic GVHD

Graft-versus-Host disease (GVHD) is a major complication of allogeneic hematopoietic cell transplantation. GVHD is an inflammatory disease initiated by T cells in the donor graft that recognize histocompatibility and other tissue antigens of the host, and is mediated by a variety of effector cells and inflammatory cytokines. GVHD presents in both acute and chronic forms and may be restricted to a single organ or tissue or may be widespread. The symptoms of cGVHD typically present at between 100 days and three years post-transplant.

Treatment of chronic GI GVHD is a challenge because it can be refractory to frontline immunosuppression. High-dose systemic corticosteroids are used with some success but carry significant toxicity. The risks of prolonged immunosuppression include local and disseminated infections, Epstein-Barr virus associated lymphoproliferative disease, hypothalamic-pituitary-adrenal (HPA) axis suppression, myopathy, glucose intolerance, neuropsychiatric disease and bone demineralization.

Chronic GI GVHD affects approximately 6,000 patients annually in the United States and an approximately equal amount in the rest-of-world.